Heart valve sealing devices

ABSTRACT

This disclosure pertains generally to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices. In some cases, a spacer having a single anchor can be implanted within a native heart valve. In some cases, a spacer having dual anchors can be implanted within a native heart valve. In some cases, devices can be used to extend the effective length of a native heart valve leaflet.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Divisional of U.S. application Ser. No. 14/019,332filed Sep. 5, 2013, which claims the benefit of U.S. Provisional PatentApplication No. 61/697,706, filed Sep. 6, 2012, and 61/763,848, filedFeb. 12, 2013, which are each hereby incorporated herein by reference intheir entirety.

FIELD

This disclosure pertains generally to prosthetic devices and relatedmethods for helping to seal native heart valves and prevent or reduceregurgitation therethrough, as well as devices and related methods forimplanting such prosthetic devices.

BACKGROUND

The native heart valves (i.e., the aortic, pulmonary, tricuspid andmitral valves) serve critical functions in assuring the forward flow ofan adequate supply of blood through the cardiovascular system. Theseheart valves can be rendered less effective by congenital malformations,inflammatory processes, infectious conditions or disease. Such damage tothe valves can result in serious cardiovascular compromise or death. Formany years the definitive treatment for such disorders was the surgicalrepair or replacement of the valve during open heart surgery. However,such surgeries are highly invasive and are prone to many complications.Therefore, elderly and frail patients with defective heart valves oftenwent untreated. More recently, transvascular techniques have beendeveloped for introducing and implanting prosthetic devices in a mannerthat is much less invasive than open heart surgery. Such transvasculartechniques have increased in popularity due to their high success rates.

A healthy heart has a generally conical shape that tapers to a lowerapex. The heart is four-chambered and comprises the left atrium, rightatrium, left ventricle, and right ventricle. The left and right sides ofthe heart are separated by a wall generally referred to as the septum.The native mitral valve of the human heart connects the left atrium tothe left ventricle. The mitral valve has a very different anatomy thanother native heart valves. The mitral valve includes an annulus portion,which is an annular portion of the native valve tissue surrounding themitral valve orifice, and a pair of cusps, or leaflets extendingdownward from the annulus into the left ventricle. The mitral valveannulus can form a “D” shaped, oval, or otherwise out-of-roundcross-sectional shape having major and minor axes. The anterior leafletcan be larger than the posterior leaflet, forming a generally “C” shapedboundary between the abutting free edges of the leaflets when they areclosed together.

When operating properly, the anterior leaflet and the posterior leafletfunction together as a one-way valve to allow blood to flow only fromthe left atrium to the left ventricle. The left atrium receivesoxygenated blood from the pulmonary veins. When the muscles of the leftatrium contract and the left ventricle dilates, the oxygenated bloodthat is collected in the left atrium flows into the left ventricle. Whenthe muscles of the left atrium relax and the muscles of the leftventricle contract, the increased blood pressure in the left ventricleurges the two leaflets together, thereby closing the one-way mitralvalve so that blood cannot flow back to the left atrium and is insteadexpelled out of the left ventricle through the aortic valve. To preventthe two leaflets from prolapsing under pressure and folding back throughthe mitral annulus toward the left atrium, a plurality of fibrous cordscalled chordae tendineae tether the leaflets to papillary muscles in theleft ventricle.

Mitral regurgitation occurs when the native mitral valve fails to closeproperly and blood flows into the left atrium from the left ventricleduring the systole phase of heart contraction. Mitral regurgitation isthe most common form of valvular heart disease. Mitral regurgitation hasdifferent causes, such as leaflet prolapse, dysfunctional papillarymuscles and/or stretching of the mitral valve annulus resulting fromdilation of the left ventricle. Mitral regurgitation at a centralportion of the leaflets can be referred to as central jet mitralregurgitation and mitral regurgitation nearer to one commissure (i.e.,location where the leaflets meet) of the leaflets can be referred to aseccentric jet mitral regurgitation.

Some prior techniques for treating mitral regurgitation includestitching portions of the native mitral valve leaflets directly to oneanother. Other prior techniques include the use of a spacer implantedbetween the native mitral valve leaflets. Despite these priortechniques, there is a continuing need for improved devices and methodsfor treating mitral valve regurgitation.

SUMMARY

This disclosure pertains generally to prosthetic devices and relatedmethods for helping to seal native heart valves and prevent or reduceregurgitation therethrough, as well as devices and related methods forimplanting such prosthetic devices.

In some embodiments, a prosthetic device for treating heart valveregurgitation comprises a radially compressible and radially expandablebody having a first end, a second end, and an outer surface extendingfrom the first end to the second end and an anchor having a connectionportion and a leaflet capture portion, wherein the connection portion iscoupled to the body such that the leaflet capture portion is biasedagainst the outer surface of the body when the body is in a radiallyexpanded state, the prosthetic device is configured to capture a leafletof a native heart valve between the leaflet capture portion of theanchor and the outer surface of the body, and the body is configured toprevent blood from flowing through the body in a direction extendingfrom the first end to the second end and in a direction extending fromthe second end to the first end.

In some embodiments, the outer surface of the body comprises a firstside against which the anchor is biased and a second side opposite thefirst side, and the connection portion of the anchor is coupled to thebody on the second side of the body. In some embodiments, the anchorcomprises an elongated member that is coupled to the second side of thebody at a connection location and the elongated member comprises aventricular portion that extends from the connection location across thefirst end of the body. In some embodiments, the ventricular portioncomprises first and second ventricular portions and the firstventricular portion is substantially parallel to the second ventricularportion.

In some embodiments, the body is radially compressible to a compressedstate in which a leaflet-receiving gap exists between the body and theleaflet capture portion of the anchor, and the body is resilientlyradially self-expandable to the radially expanded state. In someembodiments, the anchor comprises a first clip portion and a second clipportion, and the device is configured to capture the leaflet between thefirst and second clip portions. In some embodiments, the body is formedfrom Nitinol and is radially self-expandable to the expanded state. Insome embodiments, the body comprises a metallic frame and ablood-impermeable fabric mounted on the frame. In some embodiments, thebody is configured to allow blood to flow around the body between thebody and a non-captured leaflet during diastole, and configured to allowthe non-captured leaflet to close around the body to prevent mitralregurgitation during systole.

In some embodiments, the anchor is coupled to the first end of the bodyand the device further comprises an atrial stabilizing member extendingfrom the second end of the body. In some embodiments, the body isconfigured to move within the native heart valve along with motion ofthe captured leaflet. In some embodiments, an atrial end portion of thebody comprises a tapered shoulder that reduces in diameter moving towardthe atrial end portion of the body. In some embodiments, the bodycomprises a crescent cross-sectional shape. In some embodiments, theanchor comprises first and second anchors and the device is configuredto be secured to both native mitral valve leaflets.

In some embodiments, a prosthetic device for treating heart valveregurgitation comprises a main body portion having a connection portionand a free end portion, wherein the connection portion is configured tobe coupled to a first one of the two native mitral valve leaflets suchthat the device is implanted within a native mitral valve orifice, andwhen the device is implanted within the native mitral valve orifice, thefree end portion moves laterally toward a second one of the two nativemitral valve leaflets during systole, thereby helping to seal theorifice and reduce mitral regurgitation during systole, and the free endportion moves laterally away from the second native mitral valve leafletduring diastole to allow blood to flow from the left atrium to the leftventricle during diastole.

In some embodiments, the connection portion of the main body is thickerthan the free end portion. In some embodiments, the main body portionfurther comprises an atrial portion that contacts the native mitralvalve annulus within the left atrium adjacent to the first native mitralvalve leaflet. In some embodiments, the device further comprises aventricular anchor that clips around a lower end of the first nativemitral valve leaflet, thereby securing the device to the first nativemitral valve leaflet. In some embodiments, the anchor comprises a paddleshape with a broad upper end portion and a relatively narrow neckportion, wherein the neck portion couples the upper end portion to themain body.

In some embodiments, a prosthetic device comprises a sheet of flexible,blood-impermeable material configured to be implanted within a nativemitral valve orifice and coupled to a first one of the two native mitralleaflets or to the native mitral annulus adjacent the first nativemitral leaflet, wherein when implanted the sheet is configured toinflate with blood during systole such that a free portion of the sheetnot coupled to the first native mitral leaflet or the mitral annulusadjacent the first native mitral leaflet moves laterally toward andseals against the second of the two native mitral leaflets to reducemitral regurgitation, and when implanted the sheet is configured todeflate during diastole such that the portion of the sheet not coupledto the first native mitral leaflet or the native mitral annulus adjacentthe first native mitral leaflet moves laterally away from the secondnative mitral leaflet to allow blood to flow from the left atrium to theleft ventricle.

In some embodiments, the sheet is supported by a rigid frame that issecured to the first native mitral leaflet. In some embodiments, theframe comprises a ventricular anchor that clips around a lower end ofthe first native mitral leaflet. In some embodiments, the framecomprises an atrial portion that contacts the native mitral annuluswithin the left atrium adjacent to the first native mitral leaflet. Insome embodiments, an upper end of the sheet is secured directly to thenative mitral annulus adjacent the first native mitral leaflet or to thefirst native mitral leaflet adjacent the native mitral annulus. In someembodiments, the upper end of the sheet is secured to native tissue viarigid anchors that puncture the native tissue.

In some embodiments, the sheet comprises an annular cross-sectionalprofile perpendicular to an axis extending through the mitral orificefrom the left atrium to the left ventricle. In some embodiments, thesheet comprises a closed atrial end and an open ventricular end. In someembodiments, the open lower end is biased toward an open position and isconfigured to collapse to a closed position during diastole. In someembodiments, the sheet is supported by a rigid frame that is secured tothe first native mitral leaflet, and the frame comprises a plurality oflongitudinal splines extending from the upper end of the sheet to thelower end of the sheet. In some embodiments, the splines are biased tocause the lower end of the sheet to open away from the first nativeleaflet.

In some embodiments, a lower end of the sheet is tethered to a locationin the left ventricle below the native mitral leaflets. In someembodiments, the lower end of the sheet is tethered to the papillarymuscle heads in the left ventricle. In some embodiments, the lower endof the sheet is tethered to a lower end of the rigid frame. In someembodiments, opposing lateral ends of the lower end of the sheet aretethered to the lower end of the frame such that an intermediate portionof the lower end of the sheet can billow out away from the frame andtoward the second leaflet during systole. In some embodiments, the sheethas a generally trapezoidal shape, with a broader portion adjacent tothe mitral annulus and a narrower portion positioned between the nativemitral leaflets.

In some embodiments, a prosthetic device for treating heart valveregurgitation comprises a radially compressible and radially expandablebody having a first end, a second end, and an outer surface extendingfrom the first end to the second end, a first anchor coupled to the bodyand configured to capture the anterior native mitral valve leafletbetween the first anchor and the body to secure the device to theanterior leaflet, and a second anchor coupled to the body and configuredto capture the posterior native mitral valve leaflet between the secondanchor and the body to secure the device to the posterior leaflet,wherein when the first and second anchors capture the anterior andposterior leaflets, the body is situated within a mitral valve orificebetween the anterior and posterior leaflets, thereby decreasing a sizeof the orifice.

In some embodiments, the body is radially compressible to a collapseddelivery configuration suitable for delivering the device to the nativemitral valve, and radially expandable from the collapsed deliveryconfiguration to an expanded, operational configuration suitable foroperation in the native mitral valve. In some embodiments, the body isformed from Nitinol and is radially self-expandable from the collapsedconfiguration to the expanded configuration. In some embodiments, thedevice further comprises a sheet of blood impermeable fabric coveringthe body. In some embodiments, the body has an ellipticalcross-sectional shape. In some embodiments, the body has a crescentcross-sectional shape. In some embodiments, the body comprises aprosthetic valve. In some embodiments, the body is configured to preventblood from flowing through the body in a direction extending from thefirst end to the second end and in a direction from the second end tothe first end.

In some embodiments, a method of implanting a prosthetic sealing deviceat a native mitral valve of a heart comprises advancing a deliverycatheter to a native mitral valve region of a heart from a left atriumof the heart, the delivery catheter housing the prosthetic sealingdevice in a radially compressed configuration, advancing the prostheticsealing device distally relative to the delivery catheter such that ananchor of the prosthetic sealing device moves out of the catheter andforms a leaflet-receiving gap between an end portion of the anchor andthe delivery catheter, positioning either a posterior or an anteriormitral valve leaflet in the gap, and advancing a radially compressedbody of the prosthetic sealing device out of the delivery catheter suchthat the body self-expands radially toward the end portion of theanchor, reducing the gap, and capturing the leaflet between the body andthe end portion of the anchor, wherein the body is configured to preventthe flow of blood through the body during systole and during diastole.

In some embodiments, a non-captured one of the anterior and posteriorleaflets is not secured to the prosthetic sealing device when theprosthetic sealing device is implanted at the native mitral valve. Insome embodiments, advancing a delivery catheter through the nativemitral valve from a left atrium comprises advancing the deliverycatheter through an incision in a portion of a septum between the leftatrium and a right atrium. In some embodiments, when the deliverycatheter is advanced to the native mitral valve region of the heart, theanchor is held in a substantially straightened position within thedelivery catheter extending distally from body of the prosthetic sealingdevice.

In some embodiments, a method of implanting a prosthetic sealing deviceat a native mitral valve comprises advancing a delivery device to anative mitral valve region via a left ventricle, the delivery catheterhousing the prosthetic sealing device in a compressed configuration,allowing an anchor of the prosthetic sealing device to move radially outof the delivery device while a body of the delivery device is in acompressed configuration, such that a leaflet-receiving gap formsbetween an end portion of the anchor and the delivery device,positioning either a posterior or an anterior mitral valve leaflet inthe gap, and allowing the body of the prosthetic sealing device toradially self-expand such that the leaflet is captured between the bodyand the anchor, wherein the body is configured to prevent the flow ofblood through the body during systole and during diastole.

In some embodiments, a non-captured one of the anterior and posteriormitral valve leaflets is not secured to the prosthetic sealing devicewhen the prosthetic sealing device is implanted at the native mitralvalve. In some embodiments, advancing a delivery device to a nativemitral valve region via a left ventricle comprises inserting thedelivery device into the left ventricle through an incision in an apexof the left ventricle.

In some embodiments, a method of implanting a prosthetic sealing deviceat a native mitral valve of a heart comprises advancing a deliverysystem to a native mitral valve region of a heart from a left ventricleof the heart, the delivery system housing the prosthetic sealing devicein a radially compressed configuration, proximally retracting an outersheath of the delivery system such that anchors of the prostheticsealing device are not confined within the delivery system, advancingthe delivery system toward the left atrium of the heart such that nativemitral valve leaflets are positioned between the anchors of theprosthetic sealing device and the delivery system, proximally retractingan inner sheath of the delivery system such that a body of theprosthetic sealing device is not confined within the delivery system,wherein the body is configured to prevent the flow of blood through thebody during systole and during diastole, and removing the deliverysystem from the native mitral valve region of the heart.

In some embodiments, advancing the delivery system to the native mitralvalve region from the left ventricle comprises inserting the deliverydevice into the left ventricle through an incision in an apex of theleft ventricle. In some embodiments, when the delivery system isadvanced to the native mitral valve region of the heart, the anchor isheld in a substantially straightened position within the deliverycatheter extending distally along a side of the body of the prostheticsealing device.

In some embodiments, a method of implanting a prosthetic sealing deviceat a native mitral valve of a heart comprises advancing a deliverysystem to a native mitral valve region of a heart from a left atrium ofthe heart, the delivery system housing the prosthetic sealing device ina radially compressed configuration, proximally retracting an outersheath of the delivery system such that anchors of the prostheticsealing device are not confined within the delivery system, retractingthe delivery system toward the left atrium of the heart such that nativemitral valve leaflets are positioned between the anchors of theprosthetic sealing device and the delivery system, proximally retractingan inner sheath of the delivery system such that a body of theprosthetic sealing device is not confined within the delivery system,wherein the body is configured to prevent the flow of blood through thebody during systole and during diastole, and removing the deliverysystem from the native mitral valve region of the heart.

In some embodiments, advancing the delivery system to the native mitralvalve region from the left atrium comprises advancing the deliverysystem through an incision in a portion of a septum between the leftatrium and a right atrium. In some embodiments, when the delivery systemis advanced to the native mitral valve region of the heart, the anchoris held in a substantially straightened position within the deliverycatheter extending proximally from body of the prosthetic sealingdevice.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a portion of a human heart with an exemplary embodiment ofa sealing device attached to the native posterior mitral leaflet.

FIG. 2 shows a portion of a human heart with an exemplary embodiment ofa sealing device attached to the native anterior mitral leaflet.

FIG. 3 shows a portion of a human heart with an exemplary embodiment ofa sealing device attached to the native posterior mitral leaflet andhaving an atrial anchor.

FIG. 4 is an atrial end view of one embodiment of the sealing device ofFIG. 3 having a lattice-type atrial anchor.

FIG. 5 is an atrial end view of another embodiment of the sealing deviceof FIG. 3 having a loop-type atrial anchor.

FIG. 6 is a side view of an exemplary sealing device.

FIG. 7 is another side view of the sealing device of FIG. 6.

FIG. 8 is an atrial end view of the sealing device of FIG. 6.

FIG. 9 is an atrial end view of the sealing device of FIG. 6 implantedat a native mitral valve.

FIG. 10 shows a crescent-shaped embodiment of a sealing device.

FIG. 11 shows a sealing device having an anchor that extends from oneside of a body, around a ventricular end of the body, and along a secondside of the body.

FIGS. 12-15 show a method of deploying the sealing device of FIG. 11from a delivery sheath.

FIG. 16 is a side view of another embodiment of a sealing device havingan anchor that extends from one side of a body, around a ventricular endof the body, and along a second side of the body.

FIG. 17 is another side view of the embodiment of FIG. 16.

FIG. 18 is an atrial end view of the embodiment of FIG. 16.

FIG. 19 is a side view of an embodiment similar to that shown in FIG.16.

FIG. 20 shows the embodiment of FIG. 19 covered with a fabric layer.

FIG. 21 is a ventricular end view of the embodiment of FIG. 20 implantedat a native mitral valve.

FIG. 22 shows a portion of a human heart with an exemplary sealingdevice being implanted at the mitral region in a transeptal approach.

FIG. 23 shows a portion of a human heart with an exemplary sealingdevice being implanted at the mitral region in a transapical approach.

FIG. 24 shows a human heart with an exemplary prosthetic device attachedto a native mitral leaflet.

FIG. 25 shows an exemplary prosthetic device being coupled to a nativemitral leaflet in a transeptal approach.

FIG. 26 shows an exemplary prosthetic device being coupled to a nativemitral leaflet in a transapical approach.

FIGS. 27 and 28 show another exemplary prosthetic device being coupledto a native mitral leaflet.

FIGS. 29-31 show an exemplary prosthetic device attached to the mitralvalve region of a human heart.

FIGS. 32-34 show another exemplary prosthetic device attached to themitral valve region of a human heart.

FIG. 35 shows two exemplary prosthetic devices, each being coupled to arespective one of the native mitral valve leaflets.

FIG. 36 shows two exemplary prosthetic devices, each being coupled to arespective one of the native mitral valve leaflets.

FIG. 37 shows two exemplary prosthetic devices, each being coupled to arespective one of the native mitral valve leaflets.

FIGS. 38-41 show an exemplary prosthetic device having two anchors.

FIG. 42 shows an exemplary prosthetic device having two anchors, coupledto both of the native mitral valve leaflets.

FIG. 43 shows an exemplary prosthetic device having two anchors, coupledto both of the native mitral valve leaflets, from an atrial view.

FIG. 44 shows an exemplary prosthetic device having an elongated bodyand two anchors, coupled to both of the native mitral valve leaflets,from an atrial view.

FIG. 45 shows an exemplary prosthetic device having a valve and twoanchors, coupled to both of the native mitral valve leaflets, from anatrial view.

FIG. 46 shows an exemplary prosthetic device having a crescent-shapedbody and two anchors, coupled to both of the native mitral valveleaflets, from an atrial view.

FIGS. 47-51 show exemplary prosthetic devices having three anchors.

FIGS. 52-54 show the prosthetic device of FIGS. 38-41 implanted at anative mitral valve.

FIGS. 55 and 56 show another exemplary prosthetic device comprising aradially compressible and expandable body.

FIGS. 57 and 58 show the prosthetic device of FIGS. 55 and 56 with afabric layer.

FIGS. 59-63 show an exemplary prosthetic device with an exemplarydelivery system, in various configurations.

FIGS. 64-67 show various exemplary delivery approaches for delivering aprosthetic device to a native mitral valve.

FIG. 68 shows an exemplary prosthetic device including a nosecone.

DETAILED DESCRIPTION

Described herein are embodiments of prosthetic devices that areprimarily intended to be implanted at one of the mitral, aortic,tricuspid, or pulmonary valve regions of a human heart, as well asapparatuses and methods for implanting the same. The prosthetic devicescan be used to help restore and/or replace the functionality of adefective native mitral valve. The disclosed embodiments should not beconstrued as limiting in any way. Instead, the present disclosure isdirected toward all novel and nonobvious features and aspects of thevarious disclosed embodiments, alone and in various combinations andsub-combinations with one another.

Prosthetic Spacers

In some embodiments, a prosthetic device comprises a body and an anchor.The body is configured to be positioned within the native mitral valveorifice to help create a more effective seal between the native leafletsto prevent or minimize mitral regurgitation. The body can comprise astructure that is impervious to blood and that allows the nativeleaflets to close around the sides of the body during ventricularsystole to block blood from flowing from the left ventricle back intothe left atrium. The body is sometimes referred to herein as a spacerbecause the body can fill a space between improperly functioning nativemitral leaflets that do not naturally close completely. In someembodiments, the body can comprise a prosthetic valve structurepositioned within an annular body.

The body can have various shapes. In some embodiments, the body can havean elongated cylindrical shape having a round cross-sectional shape. Inother embodiments, the body can have an ovular cross-sectional shape, acrescent cross-sectional shape, or various other non-cylindrical shapes.The body can have an atrial or upper end positioned in or adjacent tothe left atrium, a ventricular or lower end positioned in or adjacent tothe left ventricle, and an annular side surface that extends between thenative mitral leaflets.

The anchor can be configured to secure the device to one or both of thenative mitral leaflets such that the body is positioned between the twonative leaflets. The anchor can attach to the body at a locationadjacent the ventricular end of the body. The anchor can be configuredto be positioned behind a native leaflet when implanted such that theleaflet is captured between the anchor and the body.

The prosthetic device can be configured to be implanted via a deliverysheath. The body and the anchor can be compressible to a radiallycompressed state and can be self-expandable to a radially expanded statewhen compressive pressure is released. The device can be configured toallow the anchor to self-expand radially away from the still-compressedbody initially in order to create a gap between the body and the anchor.The leaflet can then be positioned in the gap. The body can then beallowed to self-expand radially, closing the gap between the body andthe anchor and capturing the leaflet between the body and the anchor.The implantation methods for various embodiments can be different, andare more fully discussed below with respect to each embodiment.Additional information regarding these and other delivery methods can befound in U.S. Patent Application Publication No. 2011/0137397 and U.S.Provisional Patent Application No. 61/760,577, which are incorporated byreference herein in their entirety.

Some embodiments disclosed herein are generally configured to be securedto only one of the native mitral leaflets. However, other embodimentscomprise more than one anchor and can be configured to be secured toboth mitral leaflets. Unless otherwise stated, any of the embodimentsdisclosed herein that comprise a single anchor can optionally be securedto the anterior mitral leaflet or secured to the posterior mitralleaflet, regardless of whether the particular embodiments are shown asbeing secured to a particular one of the leaflets.

Furthermore, some embodiments can optionally also include one or moreatrial anchors, such as to provide additional stabilization. Unlessotherwise stated, any of the embodiments disclosed herein can optionallyinclude an atrial anchor or not include an atrial anchor, regardless ofwhether the particular embodiments are shown with an atrial anchor ornot.

Some of the disclosed prosthetic devices are prevented from atrialembolization by having the anchor hooked around a leaflet, utilizing thetension from native chordae tendinae to resist high systolic pressureurging the device toward the left atrium. During diastole, the devicescan rely on the compressive forces exerted on the leaflet that iscaptured between the body and the anchor to resist embolization into theleft ventricle.

FIG. 1 shows an exemplary embodiment of a prosthetic device 10 thatcomprises a body 12 and an anchor 14. The device 10 is secured to theposterior mitral leaflet 8 with the free end of the leaflet 8 capturedbetween the anchor 14 and the body 12. In FIG. 1, the anterior mitralleaflet 6 is shown separated from the body 12 during diastole as bloodflows from the left atrium 2 into the left ventricle 4. As the mitralleaflets open apart from each other, the device 10 can move with theposterior leaflet 8, allowing the anterior leaflet 6 to open away fromthe body 12. During systole, the back pressure on the leaflets closesthem together around the body 12 to prevent mitral regurgitation. FIG. 2shows the device 10 alternatively secured to the anterior mitral leaflet6 with the posterior mitral leaflet 8 free to articulate toward and awayfrom the device 10.

FIG. 3 shows a prosthetic device 20 having a body 22, a ventricularanchor 24, and an atrial anchor 26. The device 20 is shown secured tothe posterior leaflet 8 via the ventricular anchor 24. The atrial anchor26 can extend laterally from adjacent the atrial end of the body 22toward the mitral annulus or other lateral portions of the left atrium 2adjacent to the posterior leaflet 8. The atrial anchor 26 can helpstabilize the device. For example, the atrial anchor 26 can prevent thebody 22 from tilting and keep it oriented longitudinally along the bloodflow direction through the mitral orifice. The atrial anchor 26 can alsohelp prevent the device 20 from embolizing into the left ventricle 4.

FIGS. 4 and 5 are atrial end views showing two alternative embodimentsof atrial anchors for the device 20. FIG. 4 shows an atrial anchor 26Athat comprises a lattice-type framework supported by two connections tothe body 22, while FIG. 5 shows an atrial anchor 26B that comprises asingle elongated member extending in a loop between two connections tothe body 22. In both embodiments, the atrial anchor comprises arelatively broader or wider end portion configured to engage with theatrial tissue so as to spread out the engagement forces to avoid tissuedamage and promote increased tissue ingrowth.

FIGS. 6-8 show three views of an exemplary embodiment of the prostheticdevice 20 having a cylindrical body 22, a ventricular anchor 24, and anatrial anchor 26C. The ventricular anchor 24, as shown in FIGS. 6 and 7,comprises an elongated member that extends from two connection pointsadjacent the ventricular end of the body 22 and along one side of thebody toward the atrial end of the body. The ventricular anchor iscontoured around the generally cylindrical side surface of the body 22.The atrial anchor 26C comprises a lattice-type framework made up ofseveral diamond-shaped segments 29 coupled side-by-side in an arc. Theatrial anchor 26C further comprises three connecting members 27 couplingit to the body 22 adjacent the atrial end of the body. As shown in FIG.6, the atrial member 26C extends generally laterally to the same side ofthe body 22 as the ventricular anchor 24. The radially outward endportion of the atrial anchor can have an upward curvature to conform tothe curved geometry of the left atrium. Each of the diamond-shapedsegments 29 comprises radially outwardly pointing tip 30 that can pressinto and/or penetrate adjacent tissue in some cases.

The device 20 is shown in an expanded configuration in FIGS. 3-9. In acompressed delivery configuration, the atrial anchor 26 can be foldeddown against the side of the body 22 or extended upwardly away from thebody 22. Furthermore, the atrial anchor 26 can be circumferentiallycompressed, especially embodiments having a lattice-type structure.

The body 22 can comprise an annular metal frame 32 covered with ablood-impervious fabric 28, as shown in FIGS. 6-9. One or both ends ofthe body can also be covered with the blood-impervious fabric 28, asshown in FIG. 8. The frame 32 can comprise a mesh-like structurecomprising a plurality of interconnected metal struts, like aconventional radially compressible and expandable stent. In otherembodiments, the body can comprise a solid block of material, such asflexible sponge-like block. In some embodiments, the body 22 can behollow or filled with material.

The frame 32 can be formed from a self-expandable material, such asNitinol. When formed from a self-expandable material, the frame 32 canbe radially compressed to a delivery configuration and can be retainedin the delivery configuration by placing the device in the sheath of adelivery apparatus. When deployed from the sheath, the frame 32 canself-expand to its functional size. In other embodiments, the frame canbe formed from a plastically expandable material, such as stainlesssteel or a cobalt chromium alloy. When formed from a plasticallyexpandable material, the prosthetic device can be crimped onto adelivery apparatus and radially expanded to its functional size by aninflatable balloon or an equivalent expansion mechanism. It should benoted that any of the embodiments disclosed herein can comprise aself-expandable main body or a plastically expandable main body.

FIG. 9 is a view from the left atrium 2 of the device 20 of FIGS. 6-8implanted at a mitral valve. The body 22 is positioned between thenative leaflets 6, 8 in a sealed position with the atrial anchor 26Cengaged with the atrial tissue adjacent the posterior mitral leaflet 8.The atrial end of the body 22 is open while the ventricular end of thebody is covered with the impervious fabric 28.

FIG. 10 shows an exemplary prosthetic device 34 having a crescent shapedbody 36. The body 36 is configured to be positioned with the convex sidefacing the posterior mitral leaflet 8 and the concave side facing theanterior mitral leaflet 6. In this embodiment, the body 36 can comprisea flexible, sponge-like material. Consequently, the device 34 cancomprise two ventricular anchors to capture the anterior leaflet 6. Afirst ventricular anchor 44 is configured to be positioned behind theanterior leaflet while a second ventricular anchor 42 is configured tobe positioned between the body 36 and the anterior leaflet. The anteriorleaflet 6 is therefore captured and pinched between the two anchors 42,44 to secure the body 36 within the mitral orifice. The device 34 relieson the two anchors 42, 44 to capture the leaflet because the body 36 inthis embodiment may lack sufficient rigidity to grip the leaflet. Bothof the ventricular anchors 42, 44 can extend from adjacent a ventricularend 40 of the body 36 and extend up toward an atrial end 38 of the bodyalong the same side of the body. In other embodiments, the anchors 42,44 can be positioned on the convex side of the body 36 in order tosecure the body to the posterior leaflet. In some embodiments, theanchor 42 can be nested within the anchor 44 to provide a smallercrimped profile. In other embodiments, the anchors 42, 44 can havevarious other shapes. In still other embodiments, the body 36 can becylindrical or can have any of various other shapes described herein.

FIG. 11 shows an exemplary embodiment of a prosthetic device 50 having abody 52 and an anchor 54 that attaches to a first side of the body,extends around the ventricular end of the body, and extends along asecond side of the body opposite the first side of the body. The device50 is configured to capture a mitral leaflet between the anchor 54 andthe second side of the body 52 to secure the body within the mitralorifice. The body 52 can comprise, for example, a radially compressibleand expandable metal stent covered by a blood impermeable fabric, asdescribed above.

FIGS. 12-15 illustrate an exemplary method of deployment of the device50 from a delivery catheter 56. In FIG. 12, the body 52 is shown in aradially compressed state within the catheter 56 with the anchor 54extending distally from the ventricular end of the body in astraightened, or unfurled, state. The device 50 can be resilientlydeformed in this configuration such that the device 50 resilientlyreturns to the configuration shown in FIG. 11 when released fromconstraint. A pusher member 59 can be used to push the device 50distally relative to the catheter 56 or to hold the device 50 steady asthe catheter is retracted. In FIG. 13, the catheter 56 is retractedproximally from the device 50 and/or the device 50 is advanced distallyfrom the catheter 56 such that the elongated anchor 54 begins to extendout of the distal outlet 58 of the catheter. As the anchor 54 moves outof the outlet 58, the anchor begins to naturally return toward the shapeof FIG. 11, curling gradually as it is freed from the confining forcesof the catheter. In FIG. 14, the entire anchor 54 has moved out of thecatheter 56 and has returned to its natural shape of FIG. 11. However,the body 52 is still held in radial compression by the catheter,creating a gap 60 between the second side of the body 52 and the end ofthe anchor 54. A mitral leaflet can be positioned within the gap 60while the device is in the configuration of FIG. 14. In FIG. 15, theventricular end 62 of the body 52 begins to advance out of the outlet58, allowing the ventricular end 62 of the body to radially expand whilethe atrial end 64 of the body remains held in compression within thecatheter. This causes the body 52 to expand gradually toward the anchor54, decreasing the width of the gap 60, thereby capturing the leafletwithin the gap. Once the atrial end 64 of the body 52 is freed from thecatheter 56, the entire body 52 can expand to its fully expanded stateshown in FIG. 11, pinching or compressing the leaflet between the end ofthe anchor 54 and the side of the body. In the fully expanded stateshown in FIG. 11, a gap remains between the body 52 and the anchor 54,although the gap is desirably sized such that a leaflet is engaged bythe body and the anchor when placed in the gap. In alternativeembodiments, however, such a gap may not exist when the device is in itsfully expanded state (i.e., the anchor 54 contacts the body 52 when aleaflet is not positioned between these two components).

FIGS. 16-18 show orthogonal views of an exemplary embodiment of a device70 similar to the device 50. The device 70 can be deployed from acatheter in the manner described above with respect to FIGS. 11-15. Thedevice 70 comprises a radially self-expandable body 72 and a ventricularanchor 74. The body 72 can comprise a narrowed atrial end 76 and atapered shoulder region 77, such as to provide improved hemodynamics asblood flows around the shoulder region. The body 72 has a ventricularend 78 opposite from the atrial end 76. The ventricular anchor 74 cancomprise an elongated, curved member that connects to the body 72 at twoconnection points 80, 82 adjacent to the ventricular end 78 on a firstside of the body (i.e., the right side of the body in FIG. 16). As shownin FIGS. 16-18, the anchor 74 comprises first portions 84, 86 thatextend from the connection points 80, 82, respectively, around theventricular end 78 of the body, to a second, opposite side of the body(i.e., the left side of the body in FIG. 16). The anchor 74 furthercomprises second portions 88, 90 that extend from the first portions 84,86, respectively, along the second side of the body toward the atrialend 76 of the body. The second portions 88, 90 gradually expand apartfrom each other moving atrially toward an end portion 92 of the anchor74. The second portions 88, 90 and the end portion 92 of the anchor 74can form a paddle shape, as shown in FIG. 17, and can have acircumferential curvature that substantially matches the curvature ofthe body 72.

Note that, while FIGS. 16-18 appear to show the end portion 92 of theanchor passing within a portion of the body 72, the end portion 92actually extends around the outer surface of the body 72, as shown inFIGS. 19 and 20. The position of the end portion 92 in FIGS. 16-18illustrates the position that the anchor 74 wants to resiliently movetoward in the absence of resistance from body 72. When manufactured, theanchor 74 is provided with a pre-bend that causes the end portion 92 topress against the outer surface of the body 72, as shown in FIGS. 19 and20. This provides the device 70 the ability to apply a strong enoughclamping force on a leaflet positioned between the end portion 92 andthe body 72, even when the leaflet is very thin.

FIG. 20 also shows a blood-impervious fabric layer 94 covering the body72 which can prevent blood from flowing through the body 72. The fabriclayer can comprise, for example, polyethylene terephthalate (PET) orpolyurethane. Any of the spacers described herein (even if shown just asa frame) can include such a blood-impervious fabric layer covering thespacer, which can prevent blood from flowing through the spacer.

The device 70 can be can be deployed from a delivery catheter accordingto the method illustrated with respect to device 50 in FIGS. 11-15, byreleasing the anchor 74 first to create a leaflet-receiving gap betweenthe end portion 92 and the body 72. After positioning a leaflet in thegap, the body 72 can subsequently be freed to self-expand radiallytoward the end portion 92 to clamp the leaflet between the end portion92 and the second side of the body 72.

Because the anchor 74 extends around the ventricular end 78 of the body,the first portions 84, 86 can be provided with a larger radius ofcurvature compared to if the anchor 74 was connected to the body 72 onthe same side as the end portion 92. This large radius of curvature ofthe first portions 84, 86 can provide greater control over the clampingforces between the end portion 92 and the body 72, and provide a morerobust and durable anchor configuration, reducing stress concentrationsin the anchor 74 and connection points 80, 82. Because the body isacting as a spacer, causing the blood to flow around it, the anchor 74can pass around the ventricular end 78 of the body without obstructingthe flow of blood any more than necessary. Having the anchor members 84,86 positioned below the ventricular end of the body may not be asdesirable in embodiments where the body comprises an annular frame witha prosthetic valve within the annular frame, since the members 84, 86could restrict the flow of blood through the body to some degree.

In the case of the device 70, when the device is clipped onto a mitralleaflet between the end portion 92 and the second side of the body 72, amajority of the blood flow passes around the other three sides of thebody (i.e., the left, right, and bottom side in FIG. 18). This isillustrated in FIG. 21, which shows a ventricular end view of the device70 implanted in a mitral orifice with the posterior leaflet 8 capturedbetween the anchor 74 and the body 72. The anterior leaflet 6 is openedaway from the body 72 in FIG. 21, allowing blood to flow around threesides of the body during diastole. As shown in FIG. 21, the firstmembers 84, 86 of the anchor 74 extend across the body without blockingthe flow of blood around the body. Though not shown, during systole, theanterior leaflet 6 can close around the body 72 and create a seal withthe body and the side portions of the posterior leaflet 8 to preventregurgitation into the left atrium 2. The body 72 is shown in FIG. 21covered with the blood-impervious fabric 94 that extends around theatrial end 76 of the body and is open on the ventricular end 78 of thebody, preventing blood from flowing through the body 72. In someembodiments, the ventricular end 72 can also be covered by the fabric tofully enclose the body and provide improved hemodynamics.

The exemplary prosthetic devices disclosed herein can be delivered tothe mitral region via plural different approaches. FIG. 22 shows anexemplary prosthetic device 100 having a single anchor 102, beingdelivered with a catheter 104 via an exemplary transeptal atrialapproach. In the approach shown in FIG. 22, the catheter 104 passesthrough the inferior vena cava 110, the right atrium 112, and through anincision made in the septum 114, to reach the left atrium 2. The distalend portion 106 of the catheter 104 serves as a sheath for containingthe prosthetic device 100 in a compressed state during delivery to theheart. The delivery apparatus can further include a pusher member 116extending coaxially through the catheter 104. Once the catheter entersthe left atrium 2, implantation of the device 100 can be performedsimilar to the methods described in relation to FIGS. 11-21 herein.Alternatively, the prosthetic devices described herein can be implantedvia an atrial approach using any of the methods and/or devices describedin U.S. Patent Application Publication No. 2011/0137397 in relation toFIGS. 63-67 thereof, or in U.S. Provisional Patent Application No.61/760,577.

FIG. 23 shows an exemplary prosthetic device 120 having a single anchor122, being delivered with a delivery device 124 through the apex 126 ofthe heart in an exemplary transapical approach. In the transapicalapproach shown in FIG. 23, the prosthetic device 120 is held in acompressed configuration in a distal end of the delivery device 124 asthe delivery device is inserted through an incision in the heart apex126 and delivered through the left ventricle 4 to the mitral region. Thedelivery device 124 can have features that allow the anchor 122 toradially expand out of the delivery device 124 and away from thestill-compressed body of the prosthetic device 120, as shown in FIG. 23,to capture one of the native mitral leaflets 6 or 8. For example, thedelivery device 124 can have an outer sheath configured to release theanchor 122 while the body of the prosthetic device is held in acompressed state in an inner sheath, such as by providing a slot in thedistal end portion of sheath 124 through which the anchor 122 canextend. In some embodiments, the delivery device 124 can be similar tothe delivery device 2000 described in U.S. Patent ApplicationPublication No. 2011/0137397 (for example, with only one of the slots2028 instead of two), and can be used to implant the prosthetic device120 via methods similar to those described therein in relation to FIGS.49-62 thereof. The delivery device 124 can also be similar to thedelivery devices described in U.S. Provisional Patent Application No.61/760,577, and can be used to implant prosthetic devices via methodssimilar to those described therein.

FIG. 24 shows an exemplary prosthetic device 200 that is configured toinflate with blood and expand radially during systole and to collapseradially during diastole. The device 200 can comprise a structuralportion 202, an anchor 204, and an inflatable portion, or parachute, 206having an annular cross-sectional profile. The structural portion 202can comprise a rigid member or frame that supports one side of theparachute 206. The anchor 204 can comprise an extension of thestructural member 202 or a separate member coupled to the structuralmember and is configured to attach the device 200 to one of the nativemitral leaflets, such as the posterior native leaflet as shown in FIG.24, by capturing the leaflet between the anchor 204 and the structuralportion 202. The parachute 206 can comprise a flexible,blood-impermeable material, such as PET fabric or the like. Theparachute 206 has an open lower end 208 and a closed upper end 210.

During systole, as illustrated in FIG. 24, higher pressure in the leftventricle relative to the left atrium forces blood from the leftventricle into the open lower end 208 of the parachute. The increasedpressure in the parachute (labeled P₂ in FIG. 24) exceeds the pressurein the left atrium (labeled P₁ in FIG. 24), causing the parachute toinflate with blood and to expand radially and upwardly. At the sametime, the native leaflets 6, 8 are caused to collapse toward each other.The device 200 moves along with the leaflet to which it is attached andthe other leaflet moves toward the expanding parachute 206. When fullyinflated, the parachute 206 can seal the gap between the two nativemitral leaflets 6, 8 and prevent or reduce mitral regurgitation.

During diastole (not shown), P₁ exceeds P₂ causing the parachute 206 todeflate and collapse toward the structural portion 202. At the sametime, the two native leaflets 6, 8 are pushed apart. This allows bloodto flow from the left atrium to the left ventricle with minimalobstruction by the collapsed parachute 206.

In some embodiments, the device 200 can comprise additional structuralelements. For example, some embodiments can comprise longitudinalsplines that extend from the upper end 210 to the lower end 208 toprovide longitudinal rigidity to the parachute without impedingexpansion/contraction in the radial direction, much like a commonumbrella. In some embodiments, the device 200 can comprise a structuralmember at the lower opening 208 to prevent the lower opening from fullyclosing during diastole, such that blood can more easily enter the loweropening at the beginning of systole. In some embodiments, the device 200can comprise a biased portion that urges the lower opening 208 toward anopened position. The biased portion can comprise a spring mechanism,resiliently flexible members, or other mechanisms. In some embodiments,the device 200 can further comprise an atrial portion that extends fromor adjacent to the upper end 210 and contacts the atrial walls and/orthe atrial side of the leaflet to which the device is attached. Theatrial body can help secure the device within the mitral orifice and canprevent movement toward the left ventricle. The atrial body can comprisea separate component or an extension of the structural member 202. Theatrial body can be configured like the atrial bodies 26A, 26B or 26Cdescribed above, or can have other configurations.

FIGS. 25-28 show a prosthetic spacer 220 according to anotherembodiment, wherein the spacer 220 is coupled to one of the nativeleaflets using, for example, sutures. The spacer 220 can be formed fromany of various suitable materials, including bio-compatible materialssuch as pericardial tissue, polymers, sponge, or a gel or saline filledstructure such as a balloon. The material composition of the spacer 220can be selected to increase desirable characteristics of the spacer 220,such as performance, durability, promotion of native tissue growth, etc.The spacer 220 can be formed in any of various suitable shapes, such asa rectangle, a semi-elliptical ring or generally u-shape, or asemi-ellipse. As shown in FIG. 25, the spacer 220 can be sutured to theposterior leaflet 8 using sutures 222 via a transeptal approach, and asshown in FIG. 26, the spacer 220 can be sutured to the posterior leaflet8 using sutures 222 via a transapical approach. In use, the oppositeleaflet (the anterior leaflet in the illustrated embodiment) can coaptagainst the spacer 220 to prevent or minimize regurgitation.

FIG. 27 shows the spacer 220 after it has been sutured to the nativeposterior leaflet 8. As shown, two sutures 222 can be sufficient tocouple the spacer 220 to the leaflet 8. The sutures 222 can bepositioned as shown, with one suture 222 at either end of the spacer220, which spans across the leaflet 8. In alternative embodiments,additional or fewer sutures can be used, and the sutures can be situatedin alternative locations on the spacer 220 and/or on the leaflet 8.

FIG. 28 shows the spacer 220 being coupled to the posterior nativeleaflet 8 using a length of elongated material 224 and a pair ofslidable locking devices 226. The elongated material 224 can comprise,for example, a length of thread or suture material, or a metal orpolymeric wire, or other material suitable for suturing, such asbiological tissue. In the illustrated embodiment, a single strand ofmaterial 224 is used, although in alternative embodiments, two or morestrands 224 can be used to couple the spacer 220 to the native leaflet8. In order to couple the spacer 220 to the native posterior leaflet 8,one or both of the slidable locking devices 226 can be guided along thestrand of material 224 toward the native leaflet 8, thereby decreasingthe length of the strand 224 between the locking devices 226 until thespacer 220 is held firmly against the leaflet 8 in a desired deployedconfiguration. Because the locking devices 226 are positioned behind theposterior leaflet 8 in this configuration (that is, they are locatedbetween the native leaflet 8 and the wall of the left ventricle 4), thepotential for interference between the locking devices 226 and thecoaptation area of the leaflets 6, 8 is minimized. Once the spacer 220is situated in this configuration, any excess material 228 can betrimmed to prevent interference of the material 224 with the operationof the heart valve. The locking devices 226 can be configured to be slidor passed over a suture in one direction and resist movement in theopposite direction. Examples of locking devices (also referred to assuture securement devices) that can be implemented in the embodiment ofFIG. 28 are disclosed in co-pending application Ser. No. 13/938,071,filed Jul. 9, 2013, which is incorporated herein by reference.

FIGS. 25-28 show one spacer 220 coupled or secured to the posteriorleaflet 8. In alternative embodiments, a spacer 220 can be coupled asdescribed above to the anterior leaflet 6 in place of or in addition tothe spacer 220 coupled to the posterior leaflet 8. Except wherephysically impossible, any of the embodiments described herein can besutured to native tissue as described above with reference to spacer220, rather than or in addition to being clipped to the native leafletsusing one or more anchors.

By anchoring a prosthetic mitral device to one of the mitral leaflets,as disclosed herein, instead of anchoring the device to the walls of theleft ventricle, to the walls of the left atrium, to the native valveannulus, and/or the annulus connection portions of the native leaflets,the device anchorage is made independent of the motions of theventricular walls and atrial walls, which move significantly duringcontractions of the heart. This can provide a more stable anchorage fora prosthetic mitral device, and eliminate the risk of hook-type or corkscrew-type anchors tearing or otherwise causing trauma to the walls ofthe left ventricle or left atrium. Furthermore, the device body can beheld in a more consistent position with respect to the mitral leafletsas the leaflets articulate, eliminating undesirable motion imparted onthe device from the contraction motions of the left ventricle walls andleft atrium walls. Anchoring to a mitral leaflet can also allow for ashorter body length compared to devices having other anchorage means.

Leaflet Extension

FIG. 29 shows another exemplary prosthetic device 300 implanted at themitral valve region for treating regurgitation. The device 300 comprisesa strong, flexible sheet of blood-impermeable material. The device 300has an upper end 302 that is secured to the mitral annulus and/or theregion of a mitral valve leaflet adjacent to the mitral annulus. Theportion of the device 300 extending away from this upper end portion 302is a free end portion of the device 300. In the illustrated example, theupper end 302 is attached to the mitral annulus above the posteriorleaflet 8. In other examples, the arrangement can be reversed with thedevice 300 secured to the anterior leaflet 6. The device 300 can besecured to the native tissue by various means, such as via suturing orvia barbed anchors or microanchors 304. The upper end 302 of the device300 can be wider than the free end portion of the device 300, thus thedevice 300 can have a generally trapezoidal shape.

In FIG. 29, the lower end of the anterior leaflet 6 is not shown inorder to show the lower end of the posterior leaflet 8 and the lower end306 of the device 300 extending downwardly through the mitral orificeand into the left ventricle 4. The lower end 306 of the device can beshorter, longer, or about the same length as the leaflet to which it isattached. As shown in FIGS. 30 and 31, the lower end 306 of the devicein the illustrated embodiment extends below the lower end of theposterior leaflet during diastole (FIG. 31), and extends short of thelower end of the anterior leaflet 6 during systole (FIG. 30). The lowerend 306 can be tethered to a location in the left ventricle 4. Forexample, the lower end 306 can be tethered to the papillary muscle heads310 via tethers 308 and anchors 312, as shown, (in a manner similar tothe way in which the native chordae tendineae 314 tether the nativeleaflet 8 to the papillary muscles 310), or can be tethered to the apexof the left ventricle.

During systole, as shown in FIG. 30, the device 300 inflates or fillswith blood from the left ventricle 4 and expands laterally toward theanterior leaflet 6. This causes the lower portion of the device 300 toseal against the anterior leaflet 6, blocking the flow of blood backinto the left atrium 2. The lateral edges of the device 300 can sealbetween the two native leaflets adjacent to the commissures where thenative leaflets still naturally coapt with each other. The tethers 308prevent the lower end 306 of the device 300 from moving toward and/orinto the left atrium 2 and thereby breaking the seal with the anteriorleaflet 6. Thus, the device 300 augments the native posterior leafletand helps seal the mitral orifice in the case where the native leaflets6, 8 do not otherwise not fully coapt and allow regurgitation betweenthem.

During diastole, as shown in FIG. 31, high pressure in the left atrium 2forces the device 300 to collapse against the posterior leaflet 8,allowing blood to flow into the left ventricle 4 with minimalobstruction from the device 300.

FIG. 32 shows another exemplary prosthetic device 400 implanted at themitral valve region for treating mitral regurgitation. The device 400comprises a rigid frame 402 (e.g., a metal frame) that clips around theposterior leaflet 8 with an anchor portion 404 being positioned behindthe posterior leaflet 8 and an atrial portion 406 being positioned alongthe atrial surface of the mitral annulus and/or the portion of theposterior leaflet adjacent to the annulus. The frame 402 can secure thedevice 400 to the posterior leaflet 8 without sutures or other tissuepuncturing elements like the anchors 304 in FIGS. 29-31. The device 400also can be implanted on the anterior leaflet 6. The device 400 furthercomprises a strong, flexible sheet 408 of blood-impermeable material,like the device 300. An upper end 410 of the sheet 408 can be secured tothe frame 402 at or near the atrial portion 406. The portion of thesheet 408 extending away from this upper end portion 410 is a free endportion of the sheet 408.

In FIG. 32, the lower end of the anterior leaflet 6 is not shown inorder to show the lower end of the posterior leaflet 8 and the lowerportions of the device 400 extending downwardly through the mitralorifice and into the left ventricle 4. The lower end 412 of the sheet408 can be shorter, longer, or about the same length as the lower end ofthe leaflet to which it is attached. As shown in FIGS. 33 and 34, thelower end 412 of the sheet 408 in the illustrated embodiment extendsbelow the lower end of the posterior leaflet during diastole (FIG. 34),and extends short of the lower end of the anterior leaflet 6 duringsystole (FIG. 33). The lower end 412 can be tethered to a location inthe left ventricle 4 and/or can be tethered to one or more points 420near the lower end of the frame 402 (both tethering means are shown inFIGS. 33 and 34, though one can be used without the other). For example,in some embodiments, the lower end 412 of the sheet 408 can be tetheredto the papillary muscle heads 416 via tethers 424 and anchors 426 (in amanner similar to the way in which the native chordae tendineae 414tether the native leaflet 8 to the papillary muscles 416), and/or can betethered to the apex of the left ventricle 4. In other embodiments, thesheet 408 is tethered only to the frame 402 and tethers extending downinto the left ventricle 4 are optional. In such embodiments, one or moretethers 428 can extend from adjacent the lower end 412 of the sheet,such as from the lower lateral corners 422, and attach to the lower endof the frame at or near points 420. In some embodiments, the sheet 408can adopt a three dimensional curvature when inflated, with the lowercorners being held closer to the lower end of the frame 402 while anintermediate portion of the lower edge 412 is allowed to billow out(somewhat like a spinnaker sail) further toward the anterior leaflet 6to create a seal.

During systole, as shown in FIG. 33, the sheet 408 inflates or fillswith blood from the left ventricle 4 and expands laterally toward theanterior leaflet 6. This causes the lower portion of the sheet 408 toseal against the anterior leaflet 6, blocking the flow of blood backinto the left atrium 2. The lateral edges of the sheet 408 can sealbetween the two native leaflets adjacent to the commissures where thenative leaflets naturally coapt with each other. Thus, the device 400augments the native posterior leaflet and helps seal the mitral orificein the case where the native leaflets 6, 8 do not otherwise not fullycoapt and allow regurgitation between them.

During diastole, as shown in FIG. 34, high pressure in the left atrium 2forces the sheet 408 to collapse against the posterior leaflet 8,allowing blood to flow into the left ventricle 4 with minimalobstruction from the device 400.

FIGS. 35 and 36 show embodiments of prosthetic devices 460, 470 whichcan be used to extend the effective length of the native leaflets 6, 8.As shown in FIG. 35, a prosthetic device 460 can include a body 462 anda clip 464 for clipping the device 460 to one of the anterior orposterior native leaflets 6, 8. As shown in FIG. 36, a prosthetic device470 can include a body 472 and one or more sutures 474 for coupling thedevice 470 to one of the anterior or posterior native leaflets 6, 8. Inuse, the devices 460, 470 have free end portions extending away from thenative leaflets which extend the effective length of the nativeleaflets, thereby increasing the chance of and extent of coaptationbetween them, as described more fully below. The bodies 462, 472 cancomprise a material which is stiff enough to reduce the chance ofleaflet prolapse, and flexible enough to increase the extent of leafletcoaptation. Suitable materials can include, for example, biologicalmaterials such as pericardial tissue, goretex, silicone, polyurethane,or other polymeric materials. FIG. 35 shows that a device 460 can beused on each of the anterior and posterior native leaflets 6, 8, andFIG. 36 shows that a device 470 can be used on each of the anterior andposterior native leaflets 6, 8, but in alternative embodiments, only onesuch device can be used, or one device 460 and one device 470 can beused. FIG. 35 shows that tethers 461 can be used to tether free endportions of the bodies 462 to locations in the left ventricle, thusreducing the chances of prolapse of the prosthetic devices 460 duringsystole. The tethers 461 are optional, and can be used in a similarfashion in combination with the devices 470, 500, 502, or any othersuitable devices described herein.

FIG. 37 shows exemplary prosthetic devices 500, 502 which combinefeatures of the prosthetic spacers and the leaflet extensions describedabove. Prosthetic device 500 is shown coupled to the posterior nativeleaflet 8 while the prosthetic device 502 is shown coupled to theanterior native leaflet 6. The prosthetic devices 500, 502 includerelatively thick upper portions 504, 506, which function in a mannersimilar to the prosthetic spacers described above, and relatively thin,elongate free end portions 508, 510, which function in a manner similarto the devices 300, 400, described above. The free end portions 508, 510can have respective distal end portions 514, 516, which represent theeffective distal ends of the extended leaflets.

In use, the free end portions 508, 510 extend the effective length ofthe respective leaflets, and can facilitate initiation of leafletcoaptation during ventricular systole. During systole, the leaflets areurged toward one another due to the pressures extant in the leftventricle and left atrium. Due to the extended effective length of theleaflets, the end portions 514, 516 are more likely to coapt than werethe ends of the native leaflets without the extensions. Once coaptationis initiated, and thus blood flow from the left ventricle to the leftatrium at least partially impeded, the pressure in the left ventriclecan increase, further increasing the pressure differential between theleft ventricle and the left atrium and urging the leaflets 6, 8, furthertoward one another.

As a result, the portions of the leaflets 6, 8, and their respectiveextensions 502, 500 which coapt, increases (both in the direction fromthe end portions 514, 516 toward the left atrium 2, and from thelocations of the devices 500, 502, toward the commissure points of themitral valve), leading to a cycle of increasingly impeded blood flow,increased pressure differential, and increased coaptation of theleaflets. Thus, by facilitating initiation of coaptation, the free endportions 508, 510 can help to reduce regurgitation of blood from theleft ventricle to the left atrium during ventricular systole. Further,the upper portions 504, 506 can further help to prevent regurgitation inthe manner described above with respect to prosthetic device 10. Incases where the native leaflets 6, 8, do not experience sufficientcoaptation to prevent regurgitation, the relatively thick upper portions504, 506, can help to increase their coaptation and thereby reduceregurgitation.

FIG. 37 shows that the devices 500, 502 can be sutured to the nativeleaflets 8, 6, with sutures 512, but in alternative embodiments, thedevices 500, 502 can be clipped to the native leaflets 8, 6, asdescribed above. In alternative embodiments, only one of the devices500, 502 can be used rather than both.

Spacers Having Plural Anchors

In some embodiments, prosthetic devices can include a body and aplurality of anchors such that the body can be clipped to more than oneleaflet. Such embodiments can be used to effectively couple two or moreleaflets to one another. Thus, such a device can be used to bring nativeleaflets closer to one another and restrict their mobility in order helpincrease the chance of or extent of coaptation between the leaflets.

FIGS. 38-41 show a prosthetic spacer 600 having a body 602, a firstanchor 604 and a second anchor 606. The body 602 and anchors 604, 606can be fabricated from any of various suitable materials, and the bodyis desirably made from a relatively compressible material so that itsprofile can be reduced for delivery into a patient's heart within adelivery catheter. Alternatively, the body 602 can be inflatable (e.g.,to be inflated with a fluid such as saline or a curing epoxy or polymer)or otherwise expandable (e.g., it can be fabricated from a framecomprising a self-expanding material such as Nitinol) such that thecross section of the body 602 can be reduced for delivery into apatient's heart and then expanded to a final, deployed configurationtherein. An inflatable spacer can be particularly advantageous becauseit can allow enhanced customization of the spacer, and can allow finecontrol over the final, deployed size and configuration of the spacer.

FIGS. 38 and 39 show that the anchors can have similar structures. Eachanchor 604, 606 can be made from a single piece of relatively rigidmetallic material (e.g., an elongated wire) which can include first andsecond inner portions 608, 610, first and second bottom portions 612,614, and a main loop portion 616 extending between and connecting theupper ends of the bottom portions 612, 614. The inner portions 608, 610can be coupled rigidly to the inside of the body 602. The inner portions608, 610 can extend downwardly out of the lower end of body 602 to therespective bottom portions 612, 614, which can each curve upwardlyaround the lower end of the body 602 to meet the main loop portion 616.

FIGS. 39 and 40 show that the structure of the anchors 604, 606, andtheir connections to the body 602, biases the main loop portions 616 ofthe anchors 604, 606, into contact with the sides of the body 602. Thus,in use, the spacer 600 can be clipped to the anterior and posteriornative leaflets 6, 8, with one of the leaflets 6, 8 clipped between theanchor 604 and the body 602, and the other of the leaflets 6, 8, clippedbetween the anchor 606 and the body 602. FIG. 41 shows that the anchors604, 606 can be splayed apart so that gaps exist between the anchors604, 606, and the body 602. Thus, the spacer 600 can be introduced intothe region of a patient's native mitral valve in a closed configurationwith the anchors 604, 606 against the side of the body 602 (FIGS.38-40). The anchors 604, 606 can then be splayed apart or expanded intoan open configuration (FIG. 41) so the spacer can be positioned with thenative leaflets 6, 8, in the gaps between the anchors 604, 606 and thebody 602, after which the anchors 604, 606 can be allowed to return tothe closed configuration under their own resiliency to capture theleaflets 6, 8, and clip the spacer 600 thereto.

FIG. 42 shows that in use, the prosthetic spacer 600 can be clipped tothe posterior native mitral valve leaflet 8 using the first anchor 604,as described above with regard to prosthetic spacer 10 and shown in FIG.1, and can be clipped to the anterior native mitral valve leaflet 6using the second anchor 606, as described above with regard toprosthetic spacer 10 and shown in FIG. 2. FIG. 43 shows that when theprosthetic spacer 600 is clipped to both of the leaflets 6, 8, (e.g., atthe A2 and P2 regions of the leaflets, as identified by Carpentiernomenclature) it brings them together, decreasing the overall area ofthe mitral valve orifice, and dividing the mitral valve orifice into twoorifices 618, 620 during diastole. Thus, the area through which mitralregurgitation can occur is reduced, leaflet coaptation can be initiatedat the location of the spacer 600, and the leaflets can fully coapt moreeasily, thereby preventing or minimizing mitral regurgitation.

FIGS. 44 and 45 show alternative embodiments of dual anchor spacersclipped to the A2 and P2 regions of the anterior and posterior nativeleaflets 6, 8, as viewed from the left atrium. FIG. 44 shows anembodiment 640 in which the shape of the body of the spacer 640 isrelatively elongate such that the spacer 640 extends substantiallybetween the commissures 650, 652 of the mitral valve. As shown, in thisembodiment, the native leaflets 6, 8 are brought toward one another bythe anchors of the spacer 640, the overall area of the valve orifice isreduced, and the orifice is divided into four orifices 642, 644, 646,648 during diastole. Thus, the area through which mitral regurgitationcan occur is reduced, leaflet coaptation can be initiated at thelocation of the spacer 640, and the leaflets can fully coapt moreeasily, thereby preventing or minimizing mitral regurgitation. Inaddition, the shape of the spacer 640 can more effectively treateccentric jet mitral regurgitation, because the extension of the body ofthe spacer 640 to the commissures 650, 652 helps the leaflets 6, 8, tocoapt across the entirety of the native mitral valve orifice.

FIG. 45 shows an embodiment of a dual-anchor spacer 660 in which thebody of the spacer 660 comprises a prosthetic valve having one or moreflexible leaflets 666 that permit blood to flow into the left ventricleduring diastole and block the back flow of blood into the left atriumduring systole. In this embodiment, the native leaflets 6, 8 are broughtcloser to one another and the native mitral valve orifice is dividedinto two orifices 662, 664 during diastole. Because the body of thespacer 660 comprises a prosthetic valve, rather than a solid piece ofmaterial, the total effective open area between the leaflets duringdiastole (e.g., the area through which blood can flow) is greater inthis embodiment than in the embodiment illustrated in FIGS. 43 and 44.

In alternative embodiments, the body of a dual anchor spacer can havevarious alternative shapes. For example, cross-sectional profile of thebody can be circular, elliptical, or as shown in FIG. 46, can have agenerally crescent shape. A spacer body having a crescent shape such asspacer body 680 in FIG. 46 (viewed from the left atrium) can beparticularly advantageous because it can conform to the overall crescentshape of the anterior and posterior leaflets 6, 8 of the native mitralvalve. In such an embodiment, the concave side 682 of the crescentshaped body 680 can face the anterior native leaflet 6 while the convexside 684 of the crescent shaped body 680 can face the posterior nativeleaflet 8. FIG. 46 shows that in such an embodiment, the native mitralvalve orifice can be divided into two orifices 686, 688, each on theconcave side 682 of the spacer 680, as the convex side 684 can conformto the posterior native leaflet 8 such that no openings exist betweenthem.

FIGS. 47-51 show embodiments of spacers having three anchors, which canbe clipped to leaflets in the tricuspid valve of the human heart in amanner similar to that described above with regard to spacers in themitral valve. FIG. 47 shows a tricuspid spacer 700 having a circularbody 712 and three anchors 702. FIG. 48 shows the spacer 700 implantedin the tricuspid valve (as viewed from the right ventricle, as blood isbeing pumped out of the right ventricle), with each of the three anchors702 clipped to a respective leaflet 704 of the tricuspid valve, andthereby coupling them to one another. FIG. 49 shows the spacer 700clipped to the leaflets 704 of the tricuspid valve as blood is pumpedfrom the right atrium to the right ventricle through orifices 706, 708,710. FIG. 50 shows an alternative tricuspid spacer 720 having a body 722and three clips 724. As shown, the body 722 can have a generally Yshape. FIG. 51 shows an alternative tricuspid spacer 730 having a body732 and three clips 734. As shown, the body 732 can have a generallytriangular shape.

FIGS. 52-54 show an exemplary dual anchor spacer 750 having a body 752and first and second anchors 754, 756, positioned within a native mitralvalve. FIG. 52 shows the spacer 750 as seen from the left ventricle 4.FIG. 53 shows the spacer 750 as viewed from the left atrium 2 duringsystole, and FIG. 54 shows the spacer 750 from the left atrium 2 duringdiastole. As can be seen in FIG. 53, no openings appear through whichregurgitant flow can occur. As can be seen in FIG. 54, two openings 758,760 exist through which blood can flow from the left atrium 2 to theleft ventricle 4 during diastole, as is desirable.

A suitable delivery sequence for delivering a prosthetic spacer such asspacer 750 to the mitral valve region of a patient's heart can comprisecompressing a spacer to a compressed, delivery configuration, deliveringthe spacer to the coaptation line of a patient's native mitral valve,expanding the spacer until regurgitation in the patient's mitral valveis adequately reduced (an inflatable device can allow a physician tomake fine adjustments to the final size and configuration of the spacerbased on information received during the delivery process), manipulatingthe anchors of the spacer to an open position, capturing the nativeleaflets between the anchors and the body of the spacer, and thenmanipulating the anchors to a closed position, thereby clipping thespacer to the native mitral valve leaflets.

FIGS. 55 and 56 show an exemplary dual anchor spacer 800 comprising amain body 802 and first and second anchors 804, 806. The main body 802can comprise a plurality of interconnected struts 808 which togetherform a plurality of open cells and are arranged to form a generallyannular shape having first and second end portions 816, 818. The body802 can be formed to be radially self-expandable. For example, the body802 can be fabricated from a shape-memory material such as Nitinol,which can allow the spacer 800 to be radially compressed to a compresseddelivery configuration, delivered to one of a patient's native heartvalves, then self-expanded to an expanded functional configuration foruse within the patient's heart.

The first anchor 804 can comprise first and second end portions 810, 812which can be coupled to the first end portion 816 of the main body 802,and a loop portion 814 which can extend between the first and second endportions 810, 812. The first and second end portions 810, 812 can extendaway from the first end portion 816 of the body 802, then curl back andextend toward the second end portion 818 of the main body 802. The loopportion 814 can be coupled to the first end portion 810, extendgenerally toward the second end portion 818 of the main body 802, curlback and extend toward the first end portion 816 of the main body 802,and be coupled to the second end portion 812.

Thus, the first anchor 804 can be coupled to the first end portion 816of the main body 802 and extend along the side of the main body 802toward its second end portion 818. The second anchor 806 can have asimilar structure, and can be coupled to the main body 802 such that itextends along an opposing side of the main body 802. In this embodiment,the spacer 800 can be clipped to native tissues by pinching the nativetissues between the anchors 804, 806 and the respective sides of themain body 802. The anchors 804, 806 can be made from various suitablematerials, and in one exemplary embodiment can be fabricated from theshape-memory material Nitinol. The anchors 804, 806 in the illustratedembodiment are fabricated from separate pieces of material from the mainbody 802, and are coupled to the main body 802 using coupling mechanisms820. The coupling mechanisms 820 can be, for example, crimping ringsthat extend around a strut at the first end 816 of the main body 802 andan adjacent portion of an anchor. In alternative embodiments, however,the anchors 804, 806 and the main body 802 can be fabricated integrallywith one another (i.e., from a single piece of material). As best shownin FIG. 56, the main body 802 can have a generally elliptical or ovalshape when viewed on end, but in alternative embodiments, the main bodycan be formed to have any of various suitable shapes when viewed on end,such as a circle.

FIGS. 57 and 58 show the spacer 800 covered in a blood impermeablefabric material 822, such as made of polyethylene terephthalate (PET) orpolyurethane. The fabric material 822 can be relatively thick, strong,and soft, such as a knitted lofty cloth. The fabric material 822 can beselected to provide a softer surface for contact with the native tissue,thus reducing trauma caused to the native tissues by the implantation ofthe spacer 800, can be selected to promote native tissue ingrowth intothe spacer 800, and/or can be selected to improve the seal formedbetween native tissues and the portions of the spacer 800 they come intocontact with. Additionally, FIG. 58 shows that a fabric layer 824 can bedisposed to cover all or substantially all of the opening at the centerof the main body 802. The layer 824 can be blood impermeable, therebyblocking the flow of blood through the spacer 800. The layer 824 can beformed from the same material as fabric 822, and together the fabric 822and layer 824 can work to prevent the regurgitant flow of blood througha heart valve when the spacer has been implanted therein.

FIGS. 59-63 illustrate exemplary systems and methods which can be usedto implant the spacer 800 in a native heart valve. FIGS. 59-61illustrate exemplary systems and steps which can be used to crimp thespacer 800 to a compressed, delivery configuration, suitable fordelivery to a patient's native heart valve within a delivery device 850.FIG. 59 shows the spacer 800 with its main body 802 positioned in acrimper mechanism 900 capable of crimping the main body 802 to acompressed configuration. As shown, the anchors 804, 806 can remainoutside the crimper mechanism 900 as it is used to crimp the main bodyportion 802. For example, U.S. Pat. No. 7,530,253, which is herebyincorporated herein by reference, describes an exemplary prostheticvalve crimping device that can be used to crimp the spacer 800.

In some embodiments, the delivery device 850 can be similar to thedelivery device 2000 described in U.S. Patent Application PublicationNo. 2011/0137397 or the delivery devices described in U.S. ProvisionalPatent Application No. 61/760,577, and can be used to implant prostheticdevices via methods similar to those described therein. FIG. 59 showsthat the delivery device 850 can include an inner sheath 852 providedwith a pair of slots 854 disposed on opposing sides of the inner sheath852, and an internal locking element 856, which is axially adjustablerelative to the inner sheath 852 along a central longitudinal axis ofthe inner sheath 852. The internal locking element 856 can comprise agenerally cruciform shape, having four extension portions 858 betweenwhich are defined four voids 860. As best shown in FIG. 59, two of thevoids 860 can be aligned with the two slots 854, which can also bealigned with the portions of the anchors 804, 806 which are coupled tothe body 802 of the spacer 800. Thus, in this embodiment, the lockingelement 856 can be retracted into the inner sheath 852, thereby pullingthe main body portion 802 of the spacer 800 into the inner sheath 852 inthe same direction. As best shown in FIG. 60, as the spacer 800 ispulled into the inner sheath 852, the first and second end portions 810,812 of each of the anchors extend from the first end portion 816 of thespacer 800, through the respective voids 860 in the locking element, andthen curl out of the slots 854 in the sides of the inner sheath 852,extending along the sides of the body 802 toward the second end portion818 of the main body 802. In this way, the body 802 of the spacer 800can be pulled into the inner sheath 852 and thereby compressed to acompressed delivery configuration.

As shown in FIG. 61, after the main body portion 802 has been situatedwithin the inner sheath 852, an outer sheath 862 can be extended towardthe distal end of the device 850 so as to enclose the anchors 804, 806,thereby causing them to wrap around the inner sheath 852 and be confinedbetween the inner sheath 852 and outer sheath 862.

FIGS. 62 and 63 show a spacer 800 covered in fabric as described aboveand situated within a delivery device 870 in two differentconfigurations. FIG. 62 shows the spacer 800 having its main bodyportion 802 situated within an inner sheath 872 of the delivery device870 such that the anchors 804, 806 extend toward a distal end portion ofthe delivery device 870. In this embodiment, an outer sheath 874 can beextended distally to retain and secure the anchors 804, 806 against thesides of the inner sheath 872. Such a configuration can be used todeliver the spacer transapically, as described below. In someembodiments, retraction of the outer sheath 874 can allow the anchors804, 806 to self-expand to a splayed-apart configuration.

FIG. 62 also shows that forcible expanders, or levers, 876 can be usedto force the anchors 804, 806 to splay apart. The forcible expanders 876can be radially self-expanding levers which radially self-expand whenthe outer sheath 874 is retracted or are otherwise configured toradially expand away from the inner sheath when they are actuated by aphysician (such as by actuating a control knob on a handle that isoperatively connected to the expanders 876). The expanders 876 canalternatively be sutures or other mechanisms which can be actuated by aphysician to force the anchors 804, 806 to splay apart. In someembodiments, retraction of the outer sheath 874 can allow the anchors804, 806 to self-expand to a first splayed-apart configuration, andforcible expanders 876 can be actuated to force the anchors 804, 806 tofurther radially expand to a second splayed-apart configuration. In suchan embodiment, the expanders 876 can be actuated to cause the anchors804, 806 to radially expand to the second splayed apart configuration,and can then be actuated to allow the anchors 804, 806 to move radiallyinward and return to the first splayed-apart configuration.

FIGS. 62 and 63 illustrate the spacer 800 situated within the deliverysystem 870 such that the anchors 804, 806 extend generally along theoutside of the body 802 toward the second end portion 818 of the spacer800. In alternative embodiments, however, the configuration of the body802 and anchors 804, 806 within the delivery system 870, and thedeployment of the spacer 800 from the delivery system 870, can besimilar to that illustrated in FIGS. 12-15 with respect to device 50 anddelivery catheter 56.

FIG. 63 shows the spacer 800 having its main body portion 802 situatedwithin the inner sheath 872 of the delivery device 870 such that theanchors 804, 806 extend toward a proximal end portion of the deliverydevice 870. In this embodiment, the outer sheath 874 can be extendeddistally to retain and secure the anchors 804, 806 against the sides ofthe inner sheath 872. Such a configuration can be used to deliver thespacer transatrially, as described below.

Prosthetic spacers described herein can be delivered using minimallyinvasive approaches. FIGS. 64-67 show various approaches by which aprosthetic spacer 800 can be delivered to the region of a patient'smitral valve using a delivery system 920. For example, a prostheticspacer can be delivered via a transapical approach (FIG. 64), via atranseptal approach (FIG. 65), via a transatrial approach (FIG. 66), orvia a transfemoral approach (FIG. 67). FIGS. 64-67 show that thedelivery system 920 can comprise an outer sheath 922, an inner sheath924, and a guidewire 930 which can extend through the outer sheath 922and inner sheath 924. The delivery system 920 can also include a pusherelement (not illustrated in FIGS. 64-67, but similar to those describedabove), which can be actuated to move the spacer 800 within the innersheath 924. The outer sheath 922, inner sheath 924, guidewire 930, andpusher element can each be retracted proximally or extended distallywith respect to one another. The guidewire 930 can be used to guide thedelivery of the other components of the system 920 to an appropriatelocation within a patient's vasculature. The guidewire 930 can extendthrough a small opening or pore in the spacer 800, for example in thefabric layer 824, the small opening or pore being small enough thatsubstantial blood cannot flow therethrough.

FIGS. 64 and 67 show that the deployment of the spacer 800 to a nativemitral valve via the transapical approach can be similar to thedeployment of the valve 800 via the transfemoral approach, at leastbecause in both cases the valve is delivered to the mitral valve fromthe left ventricle. In preparing the delivery system 920 for delivery ofthe spacer 800 via the transapical or the transfemoral approach, thespacer 800 can be situated within the system 920 with the second endportion 818 of the spacer 800 disposed at the distal end of the system920 (such as shown in FIG. 62). In the transapical and the transfemoralapproaches, the delivery system 920 can be used to first deliver thespacer 800 to the region of the native mitral valve from the leftventricle. In the transapical approach, the delivery device 920 isinserted into the left ventricle via an opening in the chest and theapex of the heart. In the transfemoral approach, the delivery device 920can be inserted into a femoral artery and advanced through the aorta ina retrograde direction until the distal end of the delivery device is inthe left ventricle. The outer sheath 922 can then be retractedproximally such that the anchors 804, 806 are no longer confined withinthe outer sheath 922. In some embodiments, the anchors 804, 806 can beconfigured to self-expand to a splayed apart configuration shown inFIGS. 64 and 67. In other embodiments, as described above, the deliverysystem 920 can include a mechanism for forcing the anchors 804, 806 tosplay apart to the splayed-apart configuration (such as described abovewith respect to the embodiment of FIG. 62).

The device 920 can then be distally advanced so that the native mitralvalve leaflets are positioned between the splayed apart anchors 804,806, and the body 802. The inner sheath 924 can then be retracted sothat the body 802 is no longer confined within the inner sheath 924 andcan radially expand to an expanded configuration between the nativemitral valve leaflets. In some embodiments, the body 802 can expand suchthat the native leaflets are pinched between the body 802 and theanchors 804, 806. In alternative embodiments, as described above, themechanism for forcing the anchors 804, 806 to splay apart can beactuated to allow the anchors 804, 806 to move radially inward towardthe main body 802, thereby pinching the native leaflets between the mainbody 802 and the anchors 804, 806.

FIGS. 65 and 66 show that the deployment of the spacer 800 to a nativemitral valve via the transseptal approach can be similar to thedeployment of the valve 800 via the transatrial approach, at leastbecause in both cases the valve is delivered to the mitral valve fromthe left atrium. In preparing the delivery system 920 for delivery ofthe spacer 800 via the transseptal or the transatrial approach, thespacer 800 can be situated within the system 920 with the first endportion 816 of the spacer 800 disposed at the distal end of the system920 (such as shown in FIG. 63). In these approaches, the delivery system920 can be used to first deliver the spacer 800 to the region of thenative mitral valve from the left atrium. The outer sheath 922 can thenbe retracted proximally such that the anchors 804, 806 are no longerconfined within the outer sheath 922. In some embodiments, the anchors804, 806 can be configured to self-expand to a splayed apartconfiguration shown in FIGS. 65 and 66. In other embodiments, asdescribed above, the delivery system 920 can include a mechanism forforcing the anchors 804, 806 to splay apart to the splayed-apartconfiguration.

The system 920 can then be proximally retracted so that the nativemitral valve leaflets are positioned between the splayed apart anchors804, 806, and the body 802. The inner sheath 924 can then be retractedso that the body 802 is no longer confined within the inner sheath 924and can radially expand to an expanded configuration between the nativemitral valve leaflets. In some embodiments, the body 802 can expand suchthat the native leaflets are pinched between the body 802 and theanchors 804, 806. In alternative embodiments, as described above, themechanism for forcing the anchors 804, 806 to splay apart can beactuated to allow the anchors 804, 806 to move radially inward towardthe main body 802, thereby pinching the native leaflets between the mainbody 802 and the anchors 804, 806.

In any of the four approaches described above, once the native leafletshave been captured by the spacer 800, the delivery system 920 can beretracted and removed from the patient's vasculature. The spacer 800 canremain in the native mitral valve region, with the main body 802 beingsituated between the two native leaflets, thereby helping to reduce orprevent mitral regurgitation. It will be understood that similartechniques can be used to deliver a spacer to the native aortic,tricuspid, or pulmonary valves, depending on the needs of the patient.

In any of the four approaches described above, a marker catheter orother similar device can be used to help coordinate delivery and ensurethat a desirable delivery position is achieved. An exemplary suitablemarker catheter can include a standard catheter designed for angiograms,for example, a catheter made of a relatively low-density plasticmaterial having relatively high-density metal marker bands (e.g.,radiopaque marker bands) disposed at regular intervals thereon. Thus,the device can be introduced into a patient's vasculature and can beviewed under echocardiography or fluoroscopy. Alternatively, a markerwire can be used in place of the marker catheter. Another suitablealternative technique is left atrium angiography, which can help aphysician visualize components of a patient's heart.

A marker catheter or marker wire can be introduced into a patient'svasculature and advanced to specific areas of the vasculature near apatient's heart. For example, a marker catheter can be advanced from apatient's jugular or femoral vein into the right atrium, then into thepatient's coronary sinus. As another example, a marker catheter can beadvanced from a patient's femoral artery to the patient's circumflexartery. As another example, a marker catheter can be advanced into apatient's left atrium. Once situated in the coronary sinus, circumflexartery, left atrium, or other suitable area of a patient's vasculature,the marker catheter can be used to aid a physician in delivering andensuring desirable implantation of a prosthetic device. For example, thecoronary sinus extends around the heart near the location and elevationof the mitral valve and thus can help a physician to properly size andposition a prosthetic device for implantation.

For example, the patient's vasculature can be viewed underechocardiography, fluoroscopy, or other visualization technique whichallows a physician to view the prosthetic device being delivered and themarker catheter. A physician can first view the devices along an axisextending from the patient's left atrium to the patient's left ventricle(referred to as a “short axis”). By viewing the devices along the shortaxis, a physician can deploy (such as by inflating a balloon on which animplantable device is mounted) an implantable prosthetic device andexpand portions of the device to desired sizes and/or configurationsbased on the size and location of the marker catheter, which can providean estimate of the size of features of the native mitral valve.Alternatively or additionally, a physician can use the marker catheterto obtain an estimate of the size of a patient's native heart valve,from which estimate a prosthetic device to be implanted in the patient'snative heart valve can be selected from a set of devices havingdiffering sizes, e.g., a set of devices having differing diameters.

A physician can also view the devices along an axis perpendicular to theshort axis (referred to as a “long axis”). The long axis can haveseveral orientations, such as from commissure to commissure, but in onespecific embodiment, the long axis is oriented from the A2 location tothe P2 location of the native mitral valve. By viewing the devices alongthe long axis, a physician can align an implantable prosthetic devicerelative to the marker catheter at a desirable location along the shortaxis, such that an atrial anchor of the implantable device is situatedin the left atrium (above the marker catheter) and a ventricular anchorof the implantable device is situated in the left ventricle (below themarker catheter).

FIG. 68 shows an exemplary dual anchor spacer 950 which can be deliveredto the region of the native mitral valve via any suitable deliverymethod, for example, using the transapical, transeptal, transatrial, ortransfemoral techniques described above. The spacer 950 can include amain body 952, a first anchor 954, a second anchor 956, and a nosecone958. The spacer 950 can also include a tapered portion 962, which cancouple the main body portion 952 to a neck portion 964. The tapererportion 962 can have a variable width which can taper from the width ofthe main body 952 to the width of the neck portion 964. The neck portion964 can be configured to receive a portion of the nosecone 958 therein,and can be coupled to the nosecone 958. The main body 952 and anchors954, 956 can be fabricated from various materials, as described abovewith regard to other embodiments, and the nosecone 958 can be fabricatedfrom various suitable materials such as a long term implantable siliconeor other suitable elastomers.

The nosecone 958 can have a small pore, or opening, or slit, 966, whichcan extend through and along the length of the nosecone 958. Inaccordance with suitable delivery methods making use of a guidewire suchas guidewire 930, the guidewire can extend through the opening 966, thuseliminating the need for an opening or pore in a fabric layer. Thespacer 950 can facilitate crossing of a native heart valve due to itstapered tip, which can also provide improvements in hydrodynamics duringdiastolic blood flow. When a guidewire is removed from the opening 966,the opening can close under its own resiliency and/or blood pressure,thus leaving a sealed spacer implanted at a native heart valve.Alternatively, or in addition, the opening 966 can be sufficiently smallto prevent significant amounts of blood from travelling through thenosecone 958.

The multi-anchor spacers described herein offer several advantages overprevious techniques for treating regurgitation in heart valves. Forexample, the multi-anchor spacers described herein can be used to treatpatients whose native leaflets fail to coapt at all, whereas manyprevious techniques required some amount of native coaptation to beefficacious. Additionally, the spacers described herein (e.g., spacer640) can treat eccentric jet regurgitation more readily than other knowntechniques. While embodiments have been illustrated with two and threeanchors, the techniques described herein are generally application tospacers having any number of anchors.

General Considerations

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatuses, and systems should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The methods, apparatuses, and systems are not limited toany specific aspect or feature or combination thereof, nor do thedisclosed embodiments require that any one or more specific advantagesbe present or problems be solved.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language. Forexample, operations described sequentially may in some cases berearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods can be used in conjunction with other methods. Asused herein, the terms “a”, “an” and “at least one” encompass one ormore of the specified element. That is, if two of a particular elementare present, one of these elements is also present and thus “an” elementis present. The terms “a plurality of” and “plural” mean two or more ofthe specified element.

As used herein, the term “and/or” used between the last two of a list ofelements means any one or more of the listed elements. For example, thephrase “A, B, and/or C” means “A,” “B,” “C,” “A and B,” “A and C,” “Band C” or “A, B and C.”

As used herein, the term “coupled” generally means physically coupled orlinked and does not exclude the presence of intermediate elementsbetween the coupled items absent specific contrary language.

In view of the many possible embodiments to which the principlesdisclosed herein may be applied, it should be recognized that theillustrated embodiments are only preferred examples and should not betaken as limiting the scope of the disclosure. Rather, the scope isdefined by the following claims. We therefore claim all that comeswithin the scope and spirit of these claims.

We claim:
 1. A prosthetic device for treating heart valve regurgitationcomprising: a radially compressible and radially expandable body havinga first end, a second end, and an outer surface extending from the firstend to the second end; and an anchor having a connection portion and aleaflet capture portion, wherein: the connection portion is coupled tothe body such that the leaflet capture portion is biased against theouter surface of the body when the body is in a radially expanded state;the prosthetic device is configured to capture a leaflet of a nativeheart valve between the leaflet capture portion of the anchor and theouter surface of the body; and the body is configured to prevent bloodfrom flowing through the body in a direction extending from the firstend to the second end and in a direction extending from the second endto the first end.
 2. The device of claim 1, wherein: the outer surfaceof the body comprises a first side against which the anchor is biasedand a second side opposite the first side; and the connection portion ofthe anchor is coupled to the body on the second side of the body.
 3. Thedevice of claim 2, wherein: the anchor comprises an elongated memberthat is coupled to the second side of the body at a connection location;and the elongated member comprises a ventricular portion that extendsfrom the connection location across the first end of the body.
 4. Thedevice of claim 3, wherein the ventricular portion comprises first andsecond ventricular portions and the first ventricular portion issubstantially parallel to the second ventricular portion.
 5. The deviceof claim 1, wherein: the body is radially compressible to a compressedstate in which a leaflet-receiving gap exists between the body and theleaflet capture portion of the anchor; and the body is resilientlyradially self-expandable to the radially expanded state.
 6. The deviceof claim 1, wherein the anchor comprises a first clip portion and asecond clip portion, and wherein the device is configured to capture theleaflet between the first and second clip portions.
 7. The device ofclaim 1, wherein the body comprises a metallic frame and ablood-impermeable fabric mounted on the frame.
 8. The device of claim 1,wherein the body is configured to allow blood to flow around the bodybetween the body and a non-captured leaflet during diastole, andconfigured to allow the non-captured leaflet to close around the body toprevent mitral regurgitation during systole.
 9. The device of claim 1,wherein: the anchor is coupled to the first end of the body; and thedevice further comprises an atrial stabilizing member extending from thesecond end of the body.
 10. The device of claim 1, wherein the body isconfigured to move within the native heart valve along with motion ofthe captured leaflet.
 11. The device of claim 1, wherein an atrial endportion of the body comprises a tapered shoulder that reduces indiameter moving toward the atrial end portion of the body.
 12. Thedevice of claim 1, wherein the body comprises a crescent cross-sectionalshape.
 13. The device of claim 1, wherein the anchor comprises first andsecond anchors.
 14. The device of claim 13, wherein the device isconfigured to be secured to both native mitral valve leaflets.